FDA.reportPublic FDA data

EVERY DAY MINERAL SUN SCREEN SPF 45

Product NDC
69555-045
11-digit product format
695550045
Labeler code
69555
Product ID
69555-045_34565934-f9ac-c46a-e063-6294a90ac885
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Stream2Sea, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-11
Substance
ZINC OXIDE
Active strength
190 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
EVERY DAY MINERAL SUN SCREEN SPF 45
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE190 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ec4954f-7d60-405b-8bff-cb602fc44a4eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69555-045-01EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-02EVERY DAY MINERAL SUN SCREEN SPF 4550 mL in 1 TUBECREAM507
69555-045-03EVERY DAY MINERAL SUN SCREEN SPF 45946 mL in 1 TUBECREAM9467
69555-045-04EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-05EVERY DAY MINERAL SUN SCREEN SPF 4550 mL in 1 TUBECREAM507
69555-045-06EVERY DAY MINERAL SUN SCREEN SPF 45946 mL in 1 TUBECREAM9467
69555-045-07EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-08EVERY DAY MINERAL SUN SCREEN SPF 4550 mL in 1 TUBECREAM507
69555-045-09EVERY DAY MINERAL SUN SCREEN SPF 45946 mL in 1 TUBECREAM9467
69555-045-10EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-11EVERY DAY MINERAL SUN SCREEN SPF 4550 mL in 1 TUBECREAM507
69555-045-12EVERY DAY MINERAL SUN SCREEN SPF 45946 mL in 1 TUBECREAM9467
69555-045-13EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-14EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-15EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-16EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-17EVERY DAY MINERAL SUN SCREEN SPF 4530 mL in 1 TUBECREAM307
69555-045-18EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-19EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757
69555-045-20EVERY DAY MINERAL SUN SCREEN SPF 4575 mL in 1 TUBECREAM757

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69555-045EVERY DAY MINERAL SUN SCREEN SPF 45 (ZINC OXIDE) CREAM [STREAM2SEA, LLC]7Current NDC, Legacy NDC, 20 package rows20250513_7ec4954f-7d60-405b-8bff-cb602fc44a4e.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 255 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Softlips PearlOCTINOXATE, OCTISALATEThe Mentholatum Company43e175b4-7a48-431e-bf27-9ce7dee53f5e2024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Watermelon BlackberryDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companye1213808-4dad-4fd0-871a-04bba094a3cc2024-12-17WarningsExact identifier
application number: M020
Softlips PeppermintDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb272024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry KiwiDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Company7c8a4921-ae45-47fb-a64e-c72b1a386d0d2024-12-17WarningsExact identifier
application number: M020
Mentholatum Medicated Lip Balm CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company6edb132d-bb67-4e6c-8e18-db0305073a712024-12-17WarningsExact identifier
application number: M020
Mentholatum Medicated Lip Balm OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Companyf84cc3a4-cc9f-4a38-8b7d-cf8d6cd39df12024-12-17WarningsExact identifier
application number: M020
Mentholatum Natural Ice Sport SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company57c35631-42d3-4c6c-bcbb-e2de92b45b132024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Repair Volu-Firm Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMary Kay Inc.5f09503e-c455-4ac2-8d07-e8e66c2daa322024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Light to MediumHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.b5ca4bed-4f89-4020-a055-9d11f4cd50582024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.e5fffd20-1d22-485a-9311-4cb4f9264f6f2024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.404990e4-9499-4186-b39d-afc31834d3342024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Medium to DeepHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.6028e210-a8a3-4d84-a462-16a414c310522024-12-17WarningsExact identifier
application number: M020
Mary Kay CC Cream Sunscreen Broad Spectrum SPF 15 Very LightHOMOSALATE, OCTINOXATE, OXYBENZONEMary Kay Inc.af22b3a5-ac72-4c2a-aa7e-6b5ca07d89e82024-12-17WarningsExact identifier
application number: M020
Mary Kay TimeWise Daytime Defender Sunscreen Broad Spectrum SPF 30AVOBENZONE/OCTISALATE/OCTOCRYLENEMary Kay Inc.00f0f30d-236a-fd45-e063-6294a90a747d2024-12-17WarningsExact identifier
application number: M020
Softlips Cherry Cordial, Maple Butter, Frosted BerryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companybab8447b-58b8-4160-a91e-05f9fd09ed1d2024-12-17WarningsExact identifier
application number: M020
STUDIO FIX FLUID BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEMAKEUP ART COSMETICSfb59afc1-1dc9-f783-e053-6394a90a196b2024-12-17WarningsExact identifier
application number: M020
Mary Kay Mineral Facial Sunscreen Broad Spectrum SPF30ZINC OXIDEMary Kay Inc.0e9b15e4-e59c-f266-e063-6394a90ab81c2024-12-17WarningsExact identifier
application number: M020
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREENOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEMAKEUP ART COSMETICSe5fd3e40-de1d-4cdd-b725-4a517514ca352024-12-17WarningsExact identifier
application number: M020
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVacda1640-0d35-43dc-8734-d47b00cc85ed2024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69555-045-016955500450175 mL in 1 TUBE (69555-045-01) 75 ml2021-11-110000-00-00NoNoCurrent
69555-045-026955500450250 mL in 1 TUBE (69555-045-02) 50 ml2021-11-110000-00-00NoNoCurrent
69555-045-0369555004503946 mL in 1 TUBE (69555-045-03) 946 ml2021-11-110000-00-00NoNoCurrent
69555-045-046955500450475 mL in 1 TUBE (69555-045-04) 75 ml2021-11-110000-00-00NoNoCurrent
69555-045-056955500450550 mL in 1 TUBE (69555-045-05) 50 ml2021-11-110000-00-00NoNoCurrent
69555-045-0669555004506946 mL in 1 TUBE (69555-045-06) 946 ml2021-11-110000-00-00NoNoCurrent
69555-045-076955500450775 mL in 1 TUBE (69555-045-07) 75 ml2021-11-110000-00-00NoNoCurrent
69555-045-086955500450850 mL in 1 TUBE (69555-045-08) 50 ml2021-11-110000-00-00NoNoCurrent
69555-045-0969555004509946 mL in 1 TUBE (69555-045-09) 946 ml2021-11-110000-00-00NoNoCurrent
69555-045-106955500451075 mL in 1 TUBE (69555-045-10) 75 ml2021-11-110000-00-00NoNoCurrent
69555-045-116955500451150 mL in 1 TUBE (69555-045-11) 50 ml2021-11-110000-00-00NoNoCurrent
69555-045-1269555004512946 mL in 1 TUBE (69555-045-12) 946 ml2021-11-110000-00-00NoNoCurrent
69555-045-136955500451375 mL in 1 TUBE (69555-045-13) 75 ml2023-06-03NoNoCurrent
69555-045-146955500451475 mL in 1 TUBE (69555-045-14) 75 ml2023-12-11NoNoCurrent
69555-045-156955500451575 mL in 1 TUBE (69555-045-15) 75 ml2023-12-11NoNoCurrent
69555-045-166955500451675 mL in 1 TUBE (69555-045-16) 75 ml2024-06-03NoNoCurrent
69555-045-176955500451730 mL in 1 TUBE (69555-045-17) 30 ml2024-06-03NoNoCurrent
69555-045-186955500451875 mL in 1 TUBE (69555-045-18) 75 ml2024-09-05NoNoCurrent
69555-045-196955500451975 mL in 1 TUBE (69555-045-19) 75 ml2025-05-01NoNoCurrent
69555-045-206955500452075 mL in 1 TUBE (69555-045-20) 75 ml2025-05-01NoNoCurrent